Jump to content

Property:Results during intervention

From CAMIH

This is a property of type Text.

Showing 20 pages using this property.
D
E
'''Change in means (SD) Baseline vs. after 90 days''' - intervention arm: 11 (5) - placebo arm: 2.5 (3.6) - p=0.013  +
'''Response rate after 90 days''' - intervention arm: 7/9 - placebo arm: 2/8 - p=0.057 Of the six patients who did not respond to placebo, five were enrolled in an open-label retinol palmitate treatment arm. All five of these met criteria for response to therapy.  +
There was no significant difference in vomiting (frequency of grade) between green tea arm and placebo arm during 2nd-5th week (p=0.4-0.7).  +
2nd week: No significant difference in incidence of diarrhoe between the arms (p=0.4) 3rd-5th week: Significantly lower incidence of diarrhoea in green tea arm compared to placebo arm Green tea vs. placebo: Week 3: 14 (66.7%) vs. 9 (42.9%) p=0.04 Week 4: 16 (76.2%) vs. 7 (33.3%) p=0.002 Week 5: 17 (81.0%) vs. 8 (38.1%) p=0.002  +
No statistically significant difference; weight loss increased as the week of radiotherapy advanced (Friedman chi-square test 40.42 p < 0.001); statistically significant difference in body weight measured before radiotherapy and the first day after radiotherapy  +
Intervention arm: Mucositis developed in 13 of 15 patients; Grade 1 mucositis was found in 8 patients and Grade 2 in 5 patients; Grade 3 and 4 was not developed; dose of radiotherapy for the patients in whom mucositis developed i was 3600 cGy (range 2400-4400) Placebo arm: Grade 2 mucositis was developed in 4 patients and Grade 3 in 8 patients; Grade 4 mucositis did not occur in any patient; the median radiotherapy dose was 2000 cGy (range 1800-2800) Statistically significant differences were found in the week mucositis developed, in the severity of mucositis, and in the RT dose at which mucositis developed in favour of the intervention arm; mucositis began to appear in the second week at 1800 cGy; at the start of the third week and in the middle of the fourth week, it peaked and then began to lower; after 2400 cGy, the difference in the mucositis scores between the zinc and placebo groups was statistically significant and continued to be until 6 weeks after treatment  +
F
Results: * Higher change in SGIC for global impression and better change assessed by physician in 'general functional ability' of Sativex arm compared to placebo arm * Scores in SGIC better in Sativex arm at week 3 (p = 0.041), 5 (p = 0.022) and last visit (p = 0.022) * PGIC better at week 5 (p=0.037) compared to placebo arm  +